FDA 510(k) Chemistry Devices
FDA 510(k) Chemistry Devices - Regulatory Overview
FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.
This category includes:
- Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
- Point-of-care test systems - rapid diagnostics for hospital and home use
- Reagents and calibrators - consumables used with automated analyzers
- Urinalysis systems - dipstick readers and urine sediment analyzers
Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.
13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
Cleared
Jan 25, 2013
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN
NBW
System, Test, Blood Glucose, Over The Counter
120d
Cleared
Jan 25, 2013
LIAISON TESTOSTERONE
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
135d
Cleared
Jan 17, 2013
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
55d
Cleared
Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
74d
Cleared
Jan 14, 2013
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
220d
Cleared
Jan 10, 2013
BLOOD CULTURE HOLDER
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
128d
Cleared
Jan 09, 2013
LIQUIDCHEK DIABETES CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
Cleared
Jan 01, 2013
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
CIB
Radioimmunoassay, Angiotensin I And Renin
182d
Cleared
Dec 27, 2012
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
MXA
System, Test, Breath Nitric Oxide
27d
Cleared
Dec 27, 2012
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
JJY
Multi-analyte Controls, All Kinds (assayed)
29d
Cleared
Dec 27, 2012
QUICK SAMPLER HOLDER
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
314d
Cleared
Dec 21, 2012
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
DKZ
Enzyme Immunoassay, Amphetamine
87d
Cleared
Dec 21, 2012
GLOOKO LOGBOOK CHARTS
NBW
System, Test, Blood Glucose, Over The Counter
155d
Cleared
Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
83d
Cleared
Dec 20, 2012
NOVA ONE BLOOD GLUCOSE MONITOR
LFR
Glucose Dehydrogenase, Glucose
132d
Cleared
Dec 20, 2012
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
JIT
Calibrator, Secondary
260d
Cleared
Dec 14, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
78d
Cleared
Dec 12, 2012
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
LCP
Assay, Glycosylated Hemoglobin
170d
Cleared
Dec 11, 2012
DA01 BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
264d
Cleared
Dec 07, 2012
BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
263d
Cleared
Dec 06, 2012
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
LCP
Assay, Glycosylated Hemoglobin
143d
Cleared
Nov 30, 2012
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
CDD
Radioassay, Vitamin B12
147d
Cleared
Nov 30, 2012
GENSTRIP TEST STRIP MODEL 100-201
NBW
System, Test, Blood Glucose, Over The Counter
729d
Cleared
Nov 29, 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
85d
Cleared
Nov 28, 2012
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
MRG
System, Test, Vitamin D
111d
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